Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.

National Study, Phase III, Parallel, Double Blind, Placebo Comparative and Randomized to Evaluate the Therapeutic Efficacy and Tolerability of the Combination Naturetti® (Cassia Fistula + Senna Alexandrina Miller) in the Chronic Functional Constipation.

Primary Objective:

To evaluate the clinical efficacy of Naturetti (capsules) , considering the following criteria:

• Evacuation frequency during the treatment and follow-up period
• Consistency of stools during the treatment and follow-up period
• Global evaluation, regarding increase in frequency of evacuation and shape of stools.

Secondary Objective:

• Number of days without evacuation
• Proportion of evacuation with pain
• Proportion of evacuation with strain
• Proportion of evacuation with incomplete sensation
• Proportion of blocked stools
• Proportion of manual maneuvers to facilitate defecation
• Proportion of subjects that adhere to the diet recommended
• Proportion of the patients who have to use rescue medication
• Level of constipation improvement, according to the patient evaluation
• To evaluate clinical tolerability of the study medication by the continuous use
• To evaluate the occurrence of adverse events related to the study drug
• To identify any drug interaction.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Drug: SENNA+CASSIA; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 57 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Chronic functional constipation present, diagnosed by Rome III criteria.
• Present in most evacuations intestinal feces classified as Type 1 or 2 by the classification of Bristol.
• Women sexually active and reproductive age, using more than three months effective contraceptive method.
• Concordance, level of education and consciousness enough to cooperate with the completion of all study procedures.
• No contraindication to the use of medication in the study.
• Availability to attend all the visits of the study evaluation.

Exclusion criteria:

• History or presence of neurological disorders and / or metabolism.
• Persons with constipation caused by previous surgery.
• Presence of obstructive lesions in the gastrointestinal tract, including colorectal cancer.
• Irritable bowel syndrome or inflammatory bowel disease.
• Multiple Sclerosis
• Parkinson's disease
• Other abnormalities such as Hirschsprung's disease and Defecation Dissinrgica.
• Heart disease and / or hypertension.
• Continuous use of medication such as analgesics, anti-cholinergic (anti-histamines, antispasmodics, antidepressants, anti-psychotics), supplements with iron or aluminum, Opiates, Anti-hypertensive, CALCIUM CHANNEL BLOCKERS Preganglionic and blockers.
• Use of any other except the laxative rescue medication during the study.
• Subjects who do not confirm the diagnosis of ICFC during Phase I of the study.
• Pregnant or breast-feeding period.
• Laboratory tests outside the normal range, or the result is assessed as clinically significant by the Investigator.
• Body Mass Index (BMI) over 30.
• Participation in another clinical study within 30 days.
• Do not fill the correct Diary
• Any condition that in view of the researcher impossible the Subject to participate in the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SENNA+ CASSIA; Daily administration (capsule) of Naturetti (SENNA+ CASSIA) at bedtime, during 30 days	Drug: SENNA+CASSIA; Pharmaceutical form: capsule Route of administration: oral Dose regimen: once a day
Placebo Comparator: Placebo; Daily administration (capsule) of placebo at bedtime, during 30 days	Drug: placebo; Pharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the evacuation frequency during the treatment and follow-up period	30 and 45 days
Evaluation of the stools consistency during the treatment and follow-up period	30 and 45 days
Global evaluation, regarding increase in frequency of evacuation and shape of stools	30 and 45 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of days without evacuation	30 days
Proportion of evacuation with pain	30 days
Proportion of evacuation with strain	30 days
Proportion of evacuation with incomplete sensation	30 days
Proportion of blocked stools	30 days
Proportion of manual maneuvers to facilitate defecation	30 days
Proportion of subjects that adhere to the diet recommended	30 days
Proportion of the patients who have to use rescue medication	30 days
Level of constipation improvement, according to the patient evaluation	30 days

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Jaderson Lima, Study Director, Sanofi

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: October 13, 2009
• First Submitted That Met QC Criteria: October 13, 2009
• First Posted (Estimate): October 14, 2009

Study Record Updates

• Last Update Posted (Estimate): March 29, 2013
• Last Update Submitted That Met QC Criteria: March 28, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Anatomical; Fistula; Constipation
• Other Study ID Numbers: SENCA_L_04746